Ensuring Independence in CME Activities:

Transcription

1 Ensuring Independence in CME Activities: Compliance Expectations of the ACCME s Standards for Commercial Support SM CME is Independent What is the practice-based problem we want to address? Why does the problem exist? What do we want to change? Were we effective in producing change? Is the problem solved? If not, start again. How do we keep commercial bias out of education? The Undesirable Outcome Through their implicit or explicit, control of, or influence on, CME content, commercial interests could create commercial bias in CME (favoritism) that could result in a learner s inclination towards, or actual, use of a product or service that is more than is necessary. For non-commercial educational use only. 1

2 Since 1992, setting the national standard Mission critical as part of our public trust Effectiveness in improving practice Independence from commercial interests Valid content to prevent misuse or overuse of products. The Standards for Commercial Support SM are a key part of ACCME s overall strategy to ensure validity of CME Content Validity True New or Important Free of commercial bias Credibility or Face Validity Credentials Independent Transparency Shared Value Accreditation Council for Pharmacy Education (ACPE)* American Nurses Credentialing Center (ANCC)** American Osteopathic Association (AOA) American Academy of Family Physicians (AAFP) American Academy of Physician Assistants (AAPA) American Dental Association (ADA) Association of Regulatory Boards of Optometry (ARBO) * Adopted fully as part of Accreditation Requirements ** Adopted as part of Joint Accreditation for the Health Care Team For non-commercial educational use only. 2

3 In 2006, incorporated into ACCME Accreditation Criteria as Criteria 7-10 Compliance with ACCME s Standards for Commercial Support SM Criterion 7 Independence The provider develops activities/ educational interventions independent of commercial interests. Standards represented: SCS 1 Independence in Planning SCS 2 Resolution of Personal Conflicts of Interest SCS 6 Disclosure For non-commercial educational use only. 3

4 1.1 CME decisions free of the control of commercial interest 1.2 Commercial interest is not joint sponsor Standard 1: Independence in Planning a) identification of CME needs; b) determination of educational objectives; c) Selection and presentation of content; d) Selection of all persons and organizations that will be in a position to control the content of the CME; e) Selection of educational methods; f) Evaluation of the activity. 1.1 CME decisions free of the control of commercial interest Standard 1: Independence in Planning 1.2 Commercial interest is not joint sponsor on page 11 in your syllabus As defined by ACCME any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests. Standard 2: Resolution of Personal COI 1. All relevant relationships disclosed 2. Continue with persons who disclose 3. Implement a mechanism to identify and resolve conflicts of interest For non-commercial educational use only. 4

5 The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both A financial relationship with a commercial interest and The opportunity to affect the content of CME about the products or services of that commercial interest. Process STANDARD 2: Resolution of Personal Conflicts of interest The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. How do these circumstances create a conflict of interest? The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME an incentive to insert commercial bias. The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both A financial relationship with a commercial interest and The opportunity to affect the content of CME about the products or services of that commercial interest. Process STANDARD 2: Resolution of Personal Conflicts of interest The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. Any amount within the past 12 months Royalty Intellectual property rights Consulting fee Payment for promotional talk Ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds) Other financial benefit Of person, spouse or partner. Who needs to disclose to the provider? EVERYONE in control of content, for example: Planners Teachers/Faculty Authors Reviewers For non-commercial educational use only. 5

6 one can help fulfill the other SCS Element 2.1 The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships to the provider. SCS Element 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. one can help fulfill the other SCS Element 2.1 No commercial content SCS Element 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. one can help fulfill the other SCS Element 2.1 No financial relationships with a commercial interest SCS Element 2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners. For non-commercial educational use only. 6

7 Specific examples Sometimes the mechanism involves specifying, Who does what? within an activity Sometimes the mechanism involves content validation Providers choice of mechanism(s) to resolve potential conflicts of interest may involve: Planners Reviewers Managers Staff Faculty/ Authors Providers choice of mechanism(s) must involve: Engagement by the provider in a process that goes beyond disclosure, with necessary interventions to resolve conflict of interest implemented before the activity. For non-commercial educational use only. 7

8 Planners Reviewers Managers Staff Faculty/ Authors Standard 6: Disclosure Individuals disclosure of all in control of content to learners (including no relationships) prior to activity Disclosure of commercial support including the nature of in-kind support. No use of trade names or product group message in disclosure Commercial Support in CME (ACCME-Accredited Providers only) Other income Advertising and Exhibits Income Total commercial support with monetary value of inkind commercial support excluded Total commercial support with monetary value of in-kind commercial support included (2010 and earlier) From ACCME Annual Report Data, 2011, p 28 For non-commercial educational use only. 8

9 Managing Commercial Support 81% of ACCME-Accredited Providers receive commercial support only 21% CME activities (22% of participation) From ACCME Annual Report Data, 2011 Criterion 8 The provider appropriately manages commercial support. Standards represented: SCS 3 Appropriate Use of Commercial Support Standard 3: Appropriate Use of Commercial Support Decisions & Approval Signed Written Agreements Written policies & procedures regarding Honoraria and reimbursement of out-of-pocket expenses of planners/authors irrespective of receiving CS* No payments outside of agreement Expenditures for learners Accountability *Some elements of Standard 3 (3.7, 3.8, 3.9, 3.10, 3.11) may apply whether or not the provider receives commercial support. For non-commercial educational use only. 9

10 Criterion 9 The provider maintains a separation of promotion from education. Standard represented: SCS 4 Appropriate Management of Associated Commercial Promotion Standard 4: Managing Commercial Promotion Exhibit booths Commercial Advertising Print Computer-based Audio and video Live, face-to-face Education materials: Agent providing CME (distribution) Criterion 10 The provider actively promotes improvements in health care and NOT proprietary interests of a commercial interest. Standard represented: SCS 5 Content and Format without Commercial Bias For non-commercial educational use only. 10

11 Standard 5: Content and Format without Commercial Bias must promote improvements or quality in healthcare balanced view of therapeutic options CME is Independent What is the practice-based problem we want to address? Why does the problem exist? What do we want to change? Were we effective in producing change? Is the problem solved? If not, start again. How do we keep commercial bias out of education? Case Studies for Ensuring Independence in CME Activities For non-commercial educational use only. 11

12 Purpose To help you recognize key components in planning CME activities independent from commercial interests. Case studies Does the case meet ACCME expectations? Worksheet on page 45 Let s discuss Independence Case #1 A provider shares office space with a related organization which is an ACCME-defined commercial interest. While they never joint-sponsor with the commercial organization, sometimes during their planning process the provider will ask the editors from the commercial interest to do a courtesy review of CME content. The provider will then make changes to the content based on the editor s feedback. Does this meet ACCME s expectations for Independence? Why or why not? For non-commercial educational use only. 12

13 Case #2 Central Medical Center joint sponsors activities with several local clinics and small community hospitals. Recently, they have also agreed to joint sponsor an activity developed and being presented by MedDevice medical device manufacturer. Central Medical Center determined that the activity would meet their educational needs, since the activity is about a device recently purchased by the surgery department and the staff don t know how to use it. Does this meet ACCME s expectations for Independence? Why or why not? Let s discuss Mechanisms to Identify Conflicts of Interest Case #3 The CME Planning Committee for Western Association of Surgeons meets 3 times a year to plan their CME activities. The association asks all speakers for their CME activities to disclose relevant financial relationships in order to assess whether or not a speaker has a conflict of interest to resolve. Does this meet ACCME s expectation for identifying COI? Why or why not? For non-commercial educational use only. 13

14 Case #4 In order to identify any conflicts of interest, MECC USA asks all planners and faculty for their CME activities to disclose any significant financial relationships that they or their spouse/partner has with manufacturers of products or services that will be discussed in the activity which are: Over $5000 Last 12 months When a relationship exists, they ask for the name of CI and nature of financial interest. Does this meet ACCME s expectation for identifying COI? Why or why not? Let s discuss Mechanisms to Resolve Conflicts of Interest Case #5 Oz Medical School uses a form to gather information about relevant financial relationships from their planners and speakers. On the bottom of this form, the person completing it is asked to indicate how they will be resolving their own conflict of interest (if applicable). Does this meet ACCME s expectation for resolving COI? Why or why not? For non-commercial educational use only. 14

15 Case #6 Provider A s procedure: Collects information regarding relevant financial relationships from everyone who is in control of content then, implements one of following: a. Recuse person(s) from presenting content that is related to their financial relationship(s) b. Cites multiple examples of published evidence that support clinical recommendations made in the content c. Conducts a peer review of materials; content is modified if bias is detected. Does this meet ACCME s expectation for resolving COI? Why or Why Not? Let s discuss Disclosure of Relevant Financial Relationships Case #7 At the top of the handout materials for a Tumor Board session, the provider has included the following information: None the members of the Western Medical School CME Committee, who planned this CME Activity, have any financial relationships to disclose relating to the content of the cases selected. In addition, Dr. Jones, who is facilitating this session, has no relevant financial relationships to disclose. Does this meet ACCME s expectation for disclosure of relevant financial relationships? Why or why not? For non-commercial educational use only. 15

16 Let s discuss Appropriate Use of Commercial Support Case #8 Provider ABC has scheduled a well-known speaker who expects $2,000 honorarium. ABC s policy limits honoraria to $1,500. Speaker offers to get additional $500 directly from a commercial interest. Does this meet ACCME s expectation for the appropriate use of commercial support? Why or why not? Case #9 During the week following their Annual Conference, the National Specialty Association is reviewing their documentation for the meeting, which was commercially supported by educational grants from Companies A, B, and C. For Companies A & B, the provider has a letter of agreement signed by both the commercial supporter and one of their staff members. For company C the provider has a copy of the agreement that it completed electronically when they were awarded the grant. Does this meet ACCME s expectation for the appropriate use of commercial support? Why or why not? For non-commercial educational use only. 16

17 Let s discuss Separation of Promotion from Education Case #10 For each of the past 10 years, Pharma ABC has both been a major exhibitor ( Silver Level ) at Provider Y s Annual Meeting, and has provided commercial support for a CME symposium on new approaches for treating heart disease At another cardiology meeting, a Brand Manager from Pharma ABC mentions to Provider Y that they may reduce the size of their exhibit hall sponsorship this year. Provider Y sends an to Pharma ABC s Medical Education Director explaining that Pharma ABC may not be eligible to provide grant support for the CME symposium if they don t exhibit at the Silver Level. Does this meet ACCME s expectation for the separation of promotion from education? Why or why not? For non-commercial educational use only. 17